Drug Discovery World

AUGUST 23, 2024

A new study from Korea University suggests that treatment with direct-acting antivirals (DAAs) improves liver disease-related clinical outcomes in patients with chronic hepatitis C virus (HCV) infection and reduces liver fibrosis-based disease burden. In recent years, DAAs that block replication of HCV have dramatically transformed the treatment of the disease, with around 90% effective anti-viral response rates.

Medicine 59

Medicine Development Drugs 59

Bio Pharma Dive

AUGUST 23, 2024

Agency advisers will discuss whether use of Keytruda and Opdivo should be limited in gastric cancer. Elsewhere, a buzzy genetic drug startup is exploring “strategic options.

Genetics 144

Genetics Drugs 144

Pharmaceutical Technology

AUGUST 23, 2024

Jazz’s cannabidiol oral solution, Epidiolex, is approved as an adjunct seizure treatment for three epileptic conditions in the US and Europe.

Trials 130

Trials 130

Bio Pharma Dive

AUGUST 23, 2024

Armed with clinical-stage data, Zenas BioPharma and Bicara Therapeutics both fit the profile of biotechs that have successfully pulled off IPOs this year.

Antibody 157

Antibody 157

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Pharmaceutical Technology

AUGUST 23, 2024

Novartis has partnered with Versant Ventures to establish Borealis Biosciences, a Canada based independent, discovery-stage biotech company.

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pharmaphorum

AUGUST 23, 2024

The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2 strain of SARS-CoV-2 which was dominant in the US in recent months.Both new mRNA-based vaccines have been approved for use in people aged 12 and over – and been granted emergency use authorisation for younger people aged 6 months to 11 years – and will be available within the next few days, said the drugmakers.

Vaccination 102

Vaccination Vaccine 102

Fierce Pharma

AUGUST 23, 2024

The FDA has authorized the use of | The FDA has authorized the use of new vaccines from Pfizer/BioNTech and Moderna which have been designed to defend against the Omicron KP.2 variant of SARS-CoV-2. The nod comes as word of a new omicron variant, KP.3.1.1, is beginning to eclipse KP.2 as the dominant strain of the virus in the United States.

Vaccination 102

Vaccination Vaccine 102

Pharmaceutical Technology

AUGUST 23, 2024

Rafael Holdings has signed a definitive merger agreement with Cyclo Therapeutics aiming to enhance the development of Trappsol Cyclo.

Development 130

Development 130

pharmaphorum

AUGUST 23, 2024

Novartis and VC Versant set up a new biotech, Borealis Biosciences, using a similar model to an earlier alliance to create Chinook Therapeutics

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Pharmaceutical Technology

AUGUST 23, 2024

The US FDA has approved and granted EUA for Moderna and Pfizer-BioNTech’s updated mRNA Covid-19 vaccines, Comirnaty and Spikevax.

FDA Approval 130

FDA Approval Vaccination Vaccine 130

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Fierce Pharma

AUGUST 23, 2024

Bayer’s latest round of layoffs has reportedly hit Basel, Switzerland, home of the international headquarters of the company's consumer health division. | The layoffs are the latest in Bayer's massive restructuring plan that has so far impacted more than 3,000 staffers since the start of the year.

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Pharmaceutical Technology

AUGUST 23, 2024

Integrating sustainable solutions within supply chains is imperative to ensure long-term environmental and economic viability.

Drugs 130

Drugs 130

pharmaphorum

AUGUST 23, 2024

AstraZeneca says rumours that it will relocate a planned vaccines facility from the UK to the US "do not seem to be based on facts"

Vaccination 103

Vaccination Vaccine 103

Pharmaceutical Technology

AUGUST 23, 2024

The two companies have expanded their agreement first inked in 2023, with a second ‘high-value target’ now in the crosshairs.

Antibody 130

Antibody 130

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

pharmaphorum

AUGUST 23, 2024

ICER says Geron's new drug Rytelo for myelodysplastic syndromes (MDS) is priced three to four times higher than it should be

Drugs 101

Drugs 101

Pharmaceutical Technology

AUGUST 23, 2024

AstraZeneca may relocate its vaccine manufacturing plans from the UK to US as the finance minister discusses financing cuts.

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Manufacturing Vaccination Vaccine 130

Fierce Pharma

AUGUST 23, 2024

While some analysts figure Jazz Pharmaceuticals’ Epidiolex—sold as Epidyolex abroad—could surpass the blockbuster sales threshold by the end of the decade, the cannabidiol-based seizure drug has st | On Friday, Jazz revealed that its Epidiolex oral solution failed to mass muster in a late-stage study when used as an adjunct treatment for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in young Japanese patients.

Sales 82

Sales Drugs 82

pharmaphorum

AUGUST 23, 2024

Zenas BioPharma has filed an initial public offering in the US seeking $100m+ for obexelimab, a therapy for rare disease IgG4-RD in phase 3

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

Pharma Times

AUGUST 23, 2024

Most cases go undetected until an advanced stage, as the disease rarely causes early symptoms

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Drug Discovery World

AUGUST 23, 2024

A new study indicates that anti-obesity drug semaglutide helps prevent cardiac events among overweight people who have cardiovascular disease, even if they also have heart failure. The results follow a previous finding that weekly injections of semaglutide were linked to a 20% reduction in major adverse cardiac events (MACE) such as heart attacks and strokes for people with obesity or who were overweight and had cardiovascular disease.

Trials 59

Trials Clinical Trials Clinical Trials Regulation 59

Pharma Times

AUGUST 23, 2024

The conference will be held in Basel, Switzerland from 26-28 August

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Research 104

Pharmaceutical Commerce

AUGUST 23, 2024

The latest news for pharma industry insiders.

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FDA Approval Vaccination Vaccine 105

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

Fierce Pharma

AUGUST 23, 2024

For the last 40 years, when federal legislation was ambiguous or left an administrative ga | This week on "The Top Line," we look at the potential effects of the Chevron overturn on the biopharma industry.

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Cloudbyz

AUGUST 23, 2024

In the ever-evolving landscape of clinical trials, the demand for efficiency, accuracy, and compliance has never been higher. As trials become more complex and global, the need for unified systems that can seamlessly manage data across multiple platforms is critical. At the heart of this unification is the integration of Clinical Trial Management Systems (CTMS) with Electronic Trial Master Files (eTMF) and Electronic Data Capture (EDC) systems.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Outsourcing Pharma

AUGUST 23, 2024

Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission (EC) has approved Balversa (erdafitinib) as a once-daily oral monotherapy for adult patients with unresectable or metastatic urothelial carcinoma (mUC) harboring susceptible FGFR3 genetic alterations.

Genetics 52

Genetics Drug Delivery Drugs 52

Fierce Pharma

AUGUST 23, 2024

Yuhan's Lazcluze, licensed by Johnson & Johnson, has made history as the first Korea-developed novel cancer drug to be approved by the FDA. | As part of a J&J combo, Yuhan's Lazcluze has become the first Korea-developed novel cancer drug to be approved by the FDA. Merck has optioned in on one Kelun Biotech ADC but returned another.

Licensing 52

Licensing Licensing Clinical Trials Clinical Trials 52

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Drug Channels

AUGUST 23, 2024

Today’s guest post comes from Nasir Ali, Chief Product Officer at CareMetx. Nasir reviews the cumbersome processes that affect providers’ preferences when prescribing a specialty drug to their patients. He believes that embedding the specialty drug initiation process into the provider’s workflow will benefit both patients and prescribers. Learn more by downloading CareMetx’s new 2024 Patient Services Report: Revealing Manufacturer Priorities: Patients Naturally Take Center Stage.

Manufacturing 52

Manufacturing Production Drugs 52

Outsourcing Pharma

AUGUST 23, 2024

DirectSens, an Austrian biosensor developer, has launched its latest innovation, the XpressGT RUO kit, designed for the detection of conditions related to insulin resistance, including gestational diabetes (GDM), endometriosis, and liver disease.

Insulin 52

Insulin Development 52

pharmaphorum

AUGUST 23, 2024

Discover how patient organizations play a key role in enabling drug development with the support of EFPIA. Learn more about their involvement and impact in the pharmaceutical industry.

Development 52

Development Drugs 52

Pharmaceutical Commerce

AUGUST 23, 2024

In an interview with Pharma Commerce Editor Nicholas Saraceno, Meghan Mullooly, Archbow Consulting’s Vice President, outlines the various types of available digital solutions when delivering patient services, while also sharing ways to drive efficiencies.

Development 52

Development 52

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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

Clinical Trials